	US 12,390,509 B2
	Pharmaceutical composition comprising frataxin fusion protein and methods of use thereof
Denis Boyle, Hermann, MO (US); and Thomas Ransohoff, Lexington, MA (US)
Assigned to Larimar Therapeutics, Inc., Bala Cynwyd, PA (US)
Filed by Larimar Therapeutics, Inc., Bala Cynwyd, PA (US)
Filed on Dec. 13, 2021, as Appl. No. 17/549,770.
Claims priority of provisional application 63/124,801, filed on Dec. 12, 2020.
Prior Publication US 2022/0193190 A1, Jun. 23, 2022
Int. Cl. A61K 38/17 (2006.01); A61P 21/00 (2006.01); A61P 25/00 (2006.01); C07K 14/47 (2006.01)

CPC A61K 38/1709 (2013.01) [A61P 21/00 (2018.01); A61P 25/00 (2018.01); C07K 14/47 (2013.01); C07K 2319/10 (2013.01)]

56 Claims

1. A pharmaceutical composition comprising a fusion polypeptide, a buffer, a pharmaceutically acceptable excipient and a pharmaceutically acceptable carrier, wherein:

said fusion polypeptide comprises an amino acid sequence with at least about 90% sequence identity to the amino acid sequence of SEQ ID NO: 1;

said fusion polypeptide is present in said pharmaceutical composition at a concentration of about 20 mg/mL to about 75 mg/mL;

said pharmaceutically acceptable excipient is a sugar selected from the group consisting of sucrose and mannitol;

said buffer is histidine;

wherein pH of the pharmaceutical composition is between about 5.0 and about 7.0; and

wherein said pharmaceutical composition is stable for at least 12 months when stored at a temperature of about −60° C. or lower.